The NeoBeat Efficacy Study for Newborns

Enhanced Heart Rate Monitoring of Newborns After Birth and During Resuscitation

In a multicenter randomized controlled trial the investigators will evaluate the efficacy of the novel heart rate meter NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous breathing after birth.

Study Overview

• Status: Unknown
• Conditions: Heart Rate Monitoring; Newborn Resuscitation
• Intervention / Treatment: Device: NeoBeat with a visible display

Detailed Description

Heart rate assessment immediately after birth in newborn infants is the most important clinical indicator to evaluate the status of a newborn, and critical to the correct guidance of resuscitation efforts.

One of the knowledge gaps identified by the International Liason Committee on Resuscitation (ILCOR) is how best to assess ventilation during newborn resuscitation, and improved technology for rapid application of ECG.

Laerdal Medical has developed a novel heart rate meter, NeoBeat, implementing ECG dry-electrodes in a snug-fit abdomen-shaped buckle for for rapid application on the newborn.

In a multicenter randomized controlled trial the investigators will study the efficacy of NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous respiration after birth.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siren I Rettedal, PhD; Phone Number: +47 45235742; Email: siren.irene.rettedal@sus.no
• Study Contact Backup: Name: Hege Ersdal, PhD; Phone Number: 05151; Email: hege.ersdal@safer.net

Study Locations

• Norway
  • Rogaland
    • Stavanger, Rogaland, Norway, 4068
      • Recruiting
      • Stavanger University Hospital
      • Contact: Siren I Rettedal, PhD; Phone Number: +47 45235742; Email: siren.irene.rettedal@sus.no
      • Contact: Hege L Ersdal, Associate Professor; Phone Number: +47 99647822; Email: hege.ersdal@safer.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inborn, Gestational age ≥ 28 weeks, Multiples according to availability of equipment

Exclusion Criteria:

Congenital malformations that interfere with the intervention, Non-consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; NeoBeat will be placed on all newborns immediately after birth to assess the heartrate for at least 5 minutes, or longer if the newborn needs resuscitation. Intervention subjects will have a visible display of the heart rate on the NeoBeat, to guide healthcare providers in further management of the newborn.	Device: NeoBeat with a visible display; NeoBeat (Laerdal Medical) is a CE approved novel heart rate meter, able to detect heart rate in newborns within seconds of birth. The NeoBeat uses ECG dry-electrodes in a snug-fit abdomen-shaped buckle for rapid application around the newborn's abdomen or thorax. It allows healthcare providers to reliably assess heart rate of the newborn immediately after birth and continuously during resuscitation.
No Intervention: Standard Care; NeoBeat will be placed on the newborn to collect information on heart rate, but heart rate is not displayed to the healthcare providers. If the newborn is in need of resuscitation to initiate spontaneous respiration, the baby will be transferred to the resuscitation bay. According to recommendations the heart rate should be assessed and positive pressure ventilation initiated within one minute of life. Standard care is to assess heart rate by conventional ECG and/or pulse oximetry, alternatively auscultation of the heart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of cases with adherence to resuscitation guidelines in non-breathing newborns	Defined as initiation of PPV within on minute	First minute after birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in time from birth to initiation of PPV	defined as seconds between birth and initiation of PPV	first 15 minutes of life
Change in total duration of PPV	defined as seconds of PPV in total	first hour of life
Change in time from birth to a stable HR ≥100 and 120 bpm	defined as HR ≥100 and 120 bpm for ≥ 60 seconds after discontinuing PPV	first hour of life
Change in time for pulse oximeter saturation to reach stable values of ≥ 95% without oxygen supplementation	defined as seconds between birth to reach saturation values ≥ 95% without oxygen supplementation	first hour of life
Adequate Vt delivered during PPV	defined as proportion of time of PPV with Vt ≥ 6 ml/kg	first hour of life
Change in ventilation fraction	defined as cumulative number of seconds with PPV efforts excluding pauses	first hour of life
Change in number of infants with Apgar score <7 at 5 and 10 minutes	Apgar score at 5 and 10 minutes	first 10 minutes of life
Change in NICU admission rate after resuscitation	defined as percentage of newborns needing admission to the NICU after resuscitation	first hour of life

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Collaborators: Laerdal Medical; Sykehuset Østfold
• Investigators: Study Director: Svein Skeie, MD PhD, Stavanger University Hosptial

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: SUS2019SIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No